Meet MCRA: Natasha Griffin, PhD, Director, Regulatory Affairs - In Vitro Diagnostics Dr. Natasha Griffin is a former FDA reviewer and Team Lead with over 10 years of research experience focused on different aspects of virulence and pathogenesis of bacterial pathogens preceding her time at FDA. Coming to MCRA after her 6 year tenure at FDA’s Office of In Vitro Diagnostics, Dr. Griffin has extensive knowledge of infectious disease diagnostics, including detection and identification of infectious organisms as well as antimicrobial susceptibility testing, blood culture monitoring systems and digital imaging devices. During her time at FDA, Dr. Griffin contributed to the development of policies and guidance, particularly as it pertained to antimicrobial susceptibility testing. She also served on numerous committees and working groups within the Clinical and Laboratory Standards Institute to assist in the revision and development of critical laboratory standard documents. Dr. Griffin received her Ph.D. in Molecular and Cellular Biology at Arizona State University, and her Bachelor of Science in Molecular and Cellular Biology at the University of Illinois, Urbana-Champaign. Prior to joining MCRA, Dr. Griffin was a lead reviewer and then a Team Lead in the Division of Microbiology Devices at FDA. There, she conducted and oversaw the scientific and regulatory review of hundreds of premarket applications submitted to FDA, including 510(k), 513(g), Breakthrough Designation, Emergency Use Authorization (EUA), pre-EUA, and Pre-submissions, while also consulting on numerous post-market/compliance activities. Learn more about Dr. Griffin: https://lnkd.in/e8DUCGyz #MCRA #MeetMCRA #medtechindustry #medtechinnovation #medtech #regulatoryaffairs #regulatory #USregulatory #FDA #FDAapproval #medicalinnovation #medicaldevice #medicaldevices #innovation #IVD #invitrodiagnostics #microbiology #MicrobiologyDevices #IVDregulation #molecularbiology #cellularbiology #diagnostics
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Yesterday it was the start of the FAST hub RARE-NL, which will focus on treatments for rare diseases, and drug repurposing, i.e. developing existing medicines for new indications. I am happy that I was able to contribute to the meeting yesterday by moderating one of the break-out sessions, and present a summary of the drug repurposing break-out sessions together with Saskia N. de Wildt and Saco de Visser. Regarding drug repurposing, it is also my pleasure to highlight our recent paper in Frontiers in Medicine on international initiatives to advance drug repurposing with involvement of regulators. We identified 10 initiatives, from which we could interview candidates from 8 initiatives to obtain insight in how repurposing can be advanced from a regulatory perspective. Interested to learn more? Read the results here: https://lnkd.in/eNKzw72m Congratulations to Eva Spin, who performed this study during her Master's in Pharmacy, and my UU-colleague Aukje Mantel-Teeuwisse. Lastly, great appreciation for the invaluable input from our FDA-colleagues Heather Stone, Maya Younoszai, Smith Heavner, PhD, RN. Future Affordable Sustainable Therapies, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University #drugrepurposing #regulatoryscience
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(Acting) Branch Chief, Biodefense Research Countermeasures Branch (BRCB) at the NIAID/NIH; All opinions are my own
SAVE-THE-DATE (June 9-11): "2025 Innovations in Countermeasures & Toxicology Research (ICTR) Conference" Hosted by Northwestern University - The Feinberg School of Medicine in Chicago, IL Meeting Chairs: Kurt Lu, MD, Robert Lavker, PhD, Stephanie Rangel, PhD, and Nathan Gianneschi, PhD A cooperative and collaborative conference among colleagues and subject matter experts from the forefront of #medicalcountermeasures (#MCM) discovery and development. Research scientists and product developers across disciplines of biology, chemistry, clinical and #translationalmedicine, and #drugdevelopment interested in developing #therapeutics that can treat the toxic clinical signs and symptoms after exposure to hazardous materials are welcome. Toxidromes of interest include adverse effects on the eyes, skin, lungs, nervous system, and respiratory drive. If you would like to join the contact list for further meeting updates and registration information, see https://lnkd.in/e98nSvns
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Unlocking Laboratory Excellence with RadiantLab Consulting: In today's fast-paced and ever-evolving healthcare landscape, laboratory efficiency and accuracy are paramount. At RadiantLab Consulting, we are committed to being your trusted partner for all your laboratory needs, specializing in high complexity, moderate complexity, and CLIA-waived testing services. With deep expertise spanning across laboratory disciplines—including PCR, hematology, chemistry, microbiology, and more—RadiantLab Consulting is uniquely positioned to help laboratories navigate the intricacies of modern diagnostic testing. We understand the challenges laboratories face in maintaining compliance with regulatory bodies like CLIA, CMS, COLA, CAP, and others. Our tailored consulting solutions ensure your lab not only meets but exceeds the regulatory standards required to thrive in today’s competitive environment. Our Services at a Glance: Comprehensive Regulatory Compliance Support: Expertise in CLIA, CMS, COLA, and CAP to ensure your lab is audit-ready and compliant with all relevant standards. Operational Optimization: From streamlining workflows to implementing cutting-edge technologies, we enhance your lab's operational efficiency and accuracy. Tailored Consulting Services: Whether you're establishing a new lab or improving current operations, we provide customized strategies that align with your goals. Our mission is simple: to enhance the efficiency, accuracy, and compliance of your laboratory operations. Whether you are looking to scale, improve, or simply stay ahead in the rapidly evolving laboratory sector, RadiantLab Consulting is here to guide you every step of the way. Partner with RadiantLab Consulting and unlock your lab’s full potential. #LaboratoryConsulting #RegulatoryCompliance #LaboratoryEfficiency #CLIA #PCR #CAPAccreditation #Hematology #Microbiology #Chemistry #LabOperations
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Introducing the Latest Edition of QID_JNMC! 🚀 We are thrilled to unveil the 3rd issue of our Quarterly Insights in the Department of Pharmacology newsletter! This edition is a testament to the outstanding achievements of our faculty, residents, and alumni, showcasing their remarkable contributions and departmental milestones. Dive into engaging updates on our latest activities and discover how our community is driving innovation in pharmacology. In this issue, we have featured exclusive interviews with our distinguished alumni who share their perspectives on the future of MD Pharmacology in both academia and industry. Their insights offer a glimpse into the evolving landscape of our field and provide valuable guidance for current and aspiring pharmacologists. Our theme for this issue, "Advancing Health Through Innovation: Clinical Trials," aligns with the celebration of International Clinical Trials Day on May 20. We delve into the pivotal role of clinical trials in medical research, highlighting innovative methodologies, groundbreaking research, and the impact of clinical trials on patient care and treatment advancements. 📖 Read the full issue https://lnkd.in/gfMYXBd8 #Pharmacology #ClinicalTrials #MedicalInnovation #HealthcareAdvancement #Research #Innovation #MedicalResearch #HealthcareProfessionals #QuarterlyInsights #InternationalClinicalTrialsDay
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Interesting call for papers from #CPT on a very special and interesting topic. Check it out! #CPTjournal #CallForPapers #EvidenceIntegration #PatientAccess #DrugDevelopment
Mission-driven Chief Medical Officer and Digital Health Strategist | I accelerate value in Oncology, Data Science & Virtual Health through patient-centric, physician-led technology and direct multidisciplinary care
✨ I am thrilled to lead CPT's 2025 special issue: Bench to Budget: Streamlining Evidence Integration to Enhance Drug-Development and Patient Access.💡Now is your opportunity to contribute to this important discussion! The goal of the Clinical Pharmacology & Therapeutics' high-profile “Bench to Budget” special issue is to explore the opportunities and challenges at the intersection of drug development, population health and economic evaluation. We are delighted that Sebastian Schneeweiss joins as Guest Editor. We look forward to receiving your high quality manuscripts by September 30th, 2024. 🗓 Please reach out to me with any questions. For more information, please see the Call for Papers. 📣 https://bit.ly/3KSxXzj Many thanks to the entire special issue Editorial Team Piet Van Der Graaf spiros vamvakas Mai Mehanna, MS, PhD Ya-Feng Wen Alaina Webster and the ASCPT Journal Family
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You won’t want to miss this expert panel discuss roles of #phagetherapy in #AMR infections, and increasing utilitization of #phage.
📣 Don't miss it! IPATH physician Dr. Saima Aslam will join Dr. Greg German, Krupa Parmar, and Dr. Patricia Simner on the discussion panel "#PhageTherapy and Implications for the Clinical #Microbiology Laboratory" 🔬 - next Tuesday, August 13th at 11am PT / 12pm CT / 2pm ET, hosted by American Society for Microbiology and moderated by Belkys C. Sanchez, PhD. Presentations by Filipe Cerqueira, Ph.D. and Alexis Jaramillo Cartagena, PhD. Topics to be discussed include; - Discuss the role of phage therapy in the treatment of #AMR infections. - Identify clinical situations in which phage therapy might be considered. - Describe susceptibility testing methods for clinical #phage. - Discuss the implications of increasing the utilization of phage therapy for the #clinicalmicrobiology laboratory. CC: UC San Diego School of Medicine | UC San Diego Health | UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences | UC San Diego Altman Clinical and Translational Research Institute #superbugsolution #bacteriophage #antibioticresistant #MDRO #publichealth #globalhealth #infectiousdisease #bacteriology #virology
Clinical Microbiology Virtual Journal Club
asm.org
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📢Excited to share the publication of my first ‘first-author’ paper titled 'Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review’ on Expert Review of Clinical Pharmacology!📔 📌 This work, conducted during my internship at the Københavns Universitet - University of Copenhagen, delves into the critical realm of drug-drug interactions (DDis) within Spontaneous Reporting System (SRS) databases. By incorporating key pharmacological principles, particularly focusing on temporal plausibility, we aim to enhance the accuracy of signal detection while minimizing false positives. 🔍Our scoping review, conducted using MEDLINE, offers a detailed analysis of various methods employed for DDI signal detection in SRS databases. We investigate the evaluation of co-exposure timing between interacting drugs, an area significantly underexplored in existing literature, emphasizing the need for further exploration and method development. #DrugSafety #Pharmacovigilance #Research #Clinical #Pharmacology #Drug #Review 🔗 Read the full article here:
Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review
tandfonline.com
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Research Associate | Healthcare | Medical Devices | Pharmaceuticals | Biotechnology | HealthcareIT
Future of In Vitro Diagnostics Market Download Your PDF Brochure Today: - https://lnkd.in/dhKJPngT The global in vitro diagnostics market in terms of revenue was estimated to be worth $85.2 billion in 2024 and is poised to reach $119.4 billion by 2029, growing at a CAGR of 6.9% from 2024 to 2029. The major players in this market are Roche Diagnostics UK & Ireland (Switzerland), Abbott (US), Danaher Corporation (US), Siemens Healthineers (Germany), and Thermo Fisher Scientific. #ivd #diagnostics #medicaltechnology #labtesting #healthcare #diagnostictests #clinicallaboratory #precisionmedicine #healthtech #medtech #biotechnology #labmedicine #pointofcare #pathology #medicaldevices #biochemistry #microbiology #digitalhealth #innovation #healthcareindustry
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We're thrilled to invite you to the forefront of immunogenicity analysis and interpretation at the 16th Annual Immunogenicity & Bioassay Summit! 📅 Oct 15-18, 2024 📍 Washington, D.C. 🏢 Meet our experts at Booth #14 Don't miss this opportunity to engage with cutting-edge approaches in immunogenicity assessment, bioassay optimization, and regulatory science. We're proud to contribute to the scientific discourse through two key sessions: Podium Presentation: Dr. Lauren Stevenson 📆 Oct 16, 9:30 AM Immunogenicity Assessment & Clinical Relevance "Rational ≠ Radical: A Scientific Perspective on Immunogenicity Risk and Assessment" Dr. Stevenson will explore innovative approaches to immunogenicity risk assessment, challenging current paradigms and proposing new strategies for evaluating clinically meaningful immunogenicity in biotherapeutics. Roundtable Discussion: Immunogenicity Risk Assessment Paradigms 📆 Oct 16, 2:20 - 3:10 PM "When one size does not fit all: Reevaluating immunogenicity risk assessments and the 3-tiered testing paradigm." Join us for an engaging discussion on tailoring immunogenicity risk assessments and testing strategies to meet the evolving needs of diverse biotherapeutic modalities. We look forward to collaborating with fellow scientists to advance our understanding of immunogenicity and its implications for drug development and patient outcomes. #ImmunogenicitySummit2024 #Immunogenicity #Bioanalytical #Bioanalysis #DrugDevelopment #BeAScientist #CRO #LaboratoryServices #Immunologixlabs
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We’re pleased to share that our article published earlier this year in the 𝘑𝘰𝘶𝘳𝘯𝘢𝘭 𝘧𝘰𝘳 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘗𝘩𝘢𝘳𝘮𝘢𝘤𝘰𝘭𝘰𝘨𝘺 (JCP) has been selected for Continuing Education (CE) credits! This study underscores the increasing application of pediatric PBPK models by comparing two specific models (Salem and Upreti) that predict how children’s bodies metabolize drugs, particularly focusing on the enzyme CYP3A4. It offers valuable insights into which model more accurately predicts drug behavior in children, which is essential for ensuring safe and effective pediatric dosing. Read it here: https://ow.ly/J8JS50TwBo1 Authors: Jean Dinh PharmD, PhD (Sr. Research Scientist, Certara) Trevor Johnson PhD (Principal Scientist, Certara) Marc Codaccioni PhD (Research Scientist) Rosalind Southall MSc (Sr. Scientist, CIBA Vision) Learn more about the ACCP CME/CPE credit opportunity here: https://ow.ly/CTcV50TwBnY #PediatricPharmacokinetics #CYP3A4 #DrugMetabolism #Pharmacology #PediatricDosing #DrugDevelopment
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